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Intense Therapeutic Ultrasound - Treatment for Chronic Plantar Fascia Musculoskeletal Pain Reduction

NCT03255655 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2017-12-13

Study results available
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Summary

Double-blinded feasibility study for the treatment of pain related to chronic plantar fasciitis. A total 37 patients (27 treated and 12 control/sham treated) received 2 treatments, 2 weeks apart on subcutaneous plantar fascia musculoskeletal tissue along with Standard of Care treatments as prescribed by the Principal Investigator. Patients were followed for up to 6 months after the first treatment receiving a physical exam at each follow-up visit (4, 8 and 12 weeks) and provided feedback via Patient/Subject Reported Outcome Measure surveys specific to the treated anatomy at each visit and via phone follow-up at 26 weeks after the first treatment.

Conditions

  • Chronic Plantar Fasciitis

Interventions

DEVICE

Intense Therapeutic Ultrasound Treatment - ITU

Sponsors & Collaborators

  • University of Arizona

    collaborator OTHER

  • Guided Therapy Systems

    lead INDUSTRY

Principal Investigators

  • Dan Latt, Md, Ph.D. · University of Arizona; Orthopaedic Surgery and Biomedical Engineering; Department of Orthopaedic Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-22
Primary Completion
2016-03-01
Completion
2016-03-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03255655 on ClinicalTrials.gov